The present invention relates to suture spacers and methods for their use. More particularly, the present invention relates to devices which permit a surgeon to create a consistent amount of suture slack in a suture line when tying sutures under very tight space constraints including procedures such as bladder neck stabilization and treatment of hypermobility or intrinsic sphincter deficiency. Further, the present invention relates to methods of tying sutures using the disclosed devices in such procedures.
Urinary incontinence is a widespread problem in the United States and throughout the world. Urinary incontinence affects people of all ages and can severely impact a patient both physiologically and psychologically.
In approximately 30% of the women suffering from urinary incontinence, incontinence is caused by intrinsic sphincter deficiency (ISD), a condition in which the valves of the urethral sphincter do not properly coapt. In approximately another 30% of incontinent women, incontinence is caused by hypermobility, a condition in which the muscles around the bladder relax causing the bladder neck and proximal urethra to rotate and descend in response to increases in intraabdominal pressure. Hypermobility may be the result of pregnancy or other conditions which weaken the muscles.
In addition, in an additional group of women with urinary incontinence, the condition is caused by a combination of ISD and hypermobility. In addition to the conditions described above, urinary incontinence has a number of other causes including birth defects, disease, injury, aging and urinary tract infection.
Numerous approaches for treating for urinary incontinence are available. For example, several procedures for stabilizing and/or slightly compressing the urethra so as to prevent leakage of urine have been developed. In one procedure, stabilizing or compressive force is applied directly by sutures passing through the soft tissue surrounding the urethra. Alternatively, the stabilizing or compressive force may be applied by means of a sling positioned between the urethra and the upper vaginal wall. In such procedures, sutures are secured to the sling and to a supporting structure in the body. Currently existing procedures may cause excessive pressure to be exerted on the bladder neck as a result of too little slack in the sutures.
Generally, procedures employing slings are performed with the patient in the dorsal lithotomy position. When the patient moves from the dorsal lithotomy position to a standing position the excessive pressure exerted on the bladder neck by the sling may result in chronic urinary retention or bladder instability.
Accordingly, there is a need for devices and procedures which ensure an appropriate and reproducible degree of slack in the sutures used to remedy the above mentioned disorders.
In one aspect, the invention relates to a suture spacer comprising a first member, a second member, and a border. The first member has a proximal end, a distal end, and a surface contacting side for contacting a suture emanating surface. The second member has a proximal end, a distal end, a surface contacting side for contacting suture emanating surface, and a knot formation side. The knot formation site is located on the knot formation side of the suture spacer. The border, and the distal ends of the first and second members define a suture receiving site for releasably receiving one or more sutures.
In another aspect, the invention features a suture spacer comprising a first member, a second member, and border. The first member has a proximal end and a distal end. The distal end of the first member also has a surface contacting side for contacting suture emanating surface and a knot formation side that is located generally opposite to the surface contacting side. The second member has a proximal end and a distal end with a surface contacting side for contacting suture emanating surface and a knot formation side located generally opposite to the surface contacting side. The border, and the distal ends of the first and second members define a suture receiving site for releasably receiving one or more sutures. The distance between the surface contacting sides and the knot formation sides of the first and second members defines a preselected amount of suture slack between suture emanating surface and a suture knot.
In another aspect, the invention features a suture spacer comprising a body having a surface contacting end, a knot formation end, a suture receiving lumen, and a slot. The surface contacting end may contact suture emanating surface. A suture knot maybe formed at the knot formation end. The suture receiving lumen extends from the surface contacting end to the knot formation end. The slot extends parallel to a longitudinal axis of the body. The slot is in fluid communication with the suture receiving lumen, and is adapted to releasably retain a suture within the suture receiving lumen. The distance from the surface contacting end to the knot formation end of the body and back again defines a preselected amount of slack in the suture when the suture spacer is used to form the suture knot.
In another aspect, the invention features a suture spacer comprising an elongate body having a surface contacting side, and a knot formation side. The surface contacting side can contact a suture emanating surface. A suture knot maybe formed at the knot formation end. The suture spacer has one or more suture receiving sites that extend between the surface contacting side and the knot formation side. The suture receiving sites are positioned to facilitate removal of the suture spacer after formation of the suture knot. The distance from the surface contacting side to the knot formation side and back again defines a preselected amount of suture slack.
In another aspect, the invention features a suture spacer comprising a body having a surface contacting side, a knot formation side, and an engagement member. The engagement member comprises an engagement body and at least one securing portion. The securing portion is movable between a first position in which the at least one securing portion and the surface contacting side engage the surface from which one or more sutures emanate and a second position in which the at least one securing portion releases the surface from which one or more sutures emanate.
In another aspect, the invention features a suture spacer comprising a shaft, a connector, and a slack defining member. The shaft has a proximal end and a distal end. The connector has a proximal end and a distal end. The proximal end of the connector is connected to the distal end of the shaft. The slack defining member is connected to the distal end of the connector. The slack defining member has a surface contacting side for contacting suture emanating surface and a knot formation side adjacent to which a suture knot is formed. The knot formation side of the slack defining member is disposed generally opposite to the surface contacting side. A preselected amount of suture slack is defined by a distance from the surface contacting side to the knot formation side and back again.
In another aspect, the invention features a method for producing a preselected amount of slack in a suture, comprising the steps of: transvaginally contacting a suture emanating surface with a suture spacer comprising a surface contacting side, a knot formation and a suture receiving site for releasably receiving the one or more sutures; inserting the one or more sutures emanating from the surface into the suture receiving site; tying a knot in the one or more sutures; and removing the suture spacer to produce the preselected amount of slack in the suture.
In another aspect, the invention features a method for producing a preselected amount of slack in a suture. The method comprises the following steps: contacting the suture emanating surface with a suture spacer comprising a shaft having a proximal end and a distal end, a connector, a slack defining member, and a knot formation side; tying a knot in the suture; and removing the suture spacer to produce the preselected amount of slack in the suture. The shaft is connected to the distal end of the connector having a proximal end and a distal end, the proximal end of the connector being connected to the distal end of the shaft. The slack defining member has a surface contacting side for contacting the suture emanating surface. The knot formation side is disposed generally opposite to the surface contacting side. A preselected amount of suture slack is defined by a distance from the surface contacting side to the knot formation side and back again.